Identity® 5370

GUDID H758537007

Pulse Generator DDDR

ST. JUDE MEDICAL, INC.

Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive Dual-chamber implantable pacemaker, rate-responsive
Primary Device IDH758537007
NIH Device Record Keydc61d58d-d7f8-4a34-a83d-fcaf932dde0f
Commercial Distribution Discontinuation2018-02-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIdentity®
Version Model NumberDR
Catalog Number5370
Company DUNS790268031
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734006873 [Primary]
HIBCCH758537007 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXYimplantable pacemaker Pulse-generator
KRGProgrammer, pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-04
Device Publish Date2014-10-23

On-Brand Devices [Identity® ]

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Trademark Results [Identity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IDENTITY
IDENTITY
97823933 not registered Live/Pending
Wenzhou Ouhai Glasses Co., Ltd.
2023-03-06
IDENTITY
IDENTITY
97606470 not registered Live/Pending
Identity, Inc.
2022-09-26
IDENTITY
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97606468 not registered Live/Pending
Identity, Inc.
2022-09-26
IDENTITY
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97364933 not registered Live/Pending
Two Brothers LLC
2022-04-15
IDENTITY
IDENTITY
90831228 not registered Live/Pending
Ililewa Manufacturing, LLC
2021-07-15
IDENTITY
IDENTITY
88754761 not registered Live/Pending
Identity International, LLC
2020-01-10
IDENTITY
IDENTITY
88754752 not registered Live/Pending
Identity International, LLC
2020-01-10
IDENTITY
IDENTITY
88680709 not registered Live/Pending
Zimmer, Inc.
2019-11-05
IDENTITY
IDENTITY
88194477 not registered Dead/Abandoned
Guy, Tyler
2018-11-14
IDENTITY
IDENTITY
88120022 not registered Live/Pending
Identity Management Group, LLC
2018-09-17
IDENTITY
IDENTITY
88104152 not registered Live/Pending
Transparent Agency, LLC
2018-09-04
IDENTITY
IDENTITY
88047074 not registered Dead/Abandoned
Guy, Tyler A
2018-07-20

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